Trial intelligence / Profile preview

Ondansetron + dexamethasone + dimenhydrinate vs ondansetron + dexamethasone for prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery

TCTR20210128001Phase 4

Key facts

Status
Completed
Start
Dec 2019
Countries
1
Sponsor
Faculty of Medicine, Khon Kaen University
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Small Molecules
Conditions
postoperative nausea and vomiting (PONV)
01

Overview

Phase 4, randomised, double-blind trial in postoperative nausea and vomiting (PONV) comparing ondansetron + dexamethasone + dimenhydrinate with ondansetron + dexamethasone (2 arms). Primary endpoint: incidence of postoperative nausea and vomiting. Started Dec 2019; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • ondansetron + dexamethasone + dimenhydrinate

    Participants receive a combination of ondansetron, dexamethasone, and dimenhydrinate for prophylaxis of postoperative nausea and vomiting.

  • ondansetron + dexamethasone

    Participants receive ondansetron and dexamethasone without dimenhydrinate for prophylaxis of postoperative nausea and vomiting.

03

Who it enrols

Adult women undergoing gynecologic laparoscopic surgery in Thailand, generally healthy apart from the surgical condition, with pregnant women excluded.

04

Endpoints

Primary

  • incidence of postoperative nausea and vomiting

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